Officials with the FDA have announced the approval of Vabomere (Rempex) for the treatment of complicated urinary tract infections (cUTI). Vabomere is intended for adults with cUTI, including a type of kidney infection, pyelonephritis, caused by a specific bacteria.

Vabomere contains meropenem, an antibacterial and vaborbactam that inhibits certain types of resistance mechanisms used by bacteria.

The approval is based on a clinical trial including 545 adults with cUTI, including those with pyelonephritis, who were treated intravenously with Vabomere. At the end of treatment, approximately 98% of patients treated with Vabomere compared with approximately 94% of patients treated with piperacillin/tazobactam demonstrated improvement in symptoms and a negative urine culture test.

Seven days after completing the treatment, approximately 77% of those who were treated with Vabomere had resolved symptoms and a negative urine culture, compared to approximately 73% of patients treated with piperacillin/tazobactam.

The most common adverse effects of Vabomere were headache, site reactions, and diarrhea. It is also associated with serious risks including allergic reactions. Patients with a history of anaphylaxis should not take Vabomere.

Vabomere, which was designated as a qualified infectious disease product, should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.